Tailored drug development solutions for emerging biotech
I provide tailored early drug development solutions with a focus on toxicology and regulatory consulting, virtual operations (incl. CRO and CDMO outsourcing), and overall drug development strategy. Over the last 20 years, I have managed more than 50 drug development projects and programs - small molecule, peptides, protein degraders (PROTACs), RNA therapies and various types of biologicals, such as antibodies, recombinant proteins, ADCs - for a variety of indications (oncology, inflammation, infectious diseases, endocrinology, rare diseases etc). My expert input has helped my partners to reach their regulatory milestones such as INDs and proof-of-concept with expedited timelines, minimizing unnecessary spend on operations and R&D (incl. unnecessary preclinical studies).
Over the last decade or so, I have become intimately familiar with R&D outsourcing to Chinese CROs and CDMOs (Wuxi Apptec, Pharmaron, Joinn etc.), and Australian clinical CROs (George Clinical, Southern Star, Avance, Novotech etc.). Recently, the toxicology study price difference between the top preclinical CROs in China vs. the US has sometimes been nearly 10-fold. The higher cost in the US - typically combined with much longer lead times - is simply not justifiable for most early-stage companies. As a consultant I have managed dozens of GLP toxicology studies at the leading, US FDA-inspected CROs in China, and can assist in the selection and management of your programs in the country. In clinical phase, the financial boost provided by the 43.5% tax incentive in Australia has significantly benefited numerous biotech companies. I have several years of practical experience with this, and can provide input to the subsidiary strategy, as well as clinical trials in the country.
Services
IND-enabling services
IND enabling services & solutions in support of regulatory submissions (e.g. US FDA), with disciplined and cost-effective development plan implementations. Experience on more than 30 successful IND / IMPD / CTA programs and submissions: biologicals, small molecules, recombinant proteins, peptides, oligonucleotides; indications such as oncology, CNS, GI, inflammation, rare diseases. Drafting of the electronic Common Technical Document (eCTD).
STRATEGIC CONSulting and program management
I have a successful leadership track record in taking early-stage biotech companies from seed-stage financing into signal-generating Phase 1 trials, all the way up to randomized clinical trials. I will tailor a path towards value-creating milestones (such as IND, clinical PoC), based on the evaluation of the maturity of a compound's development, anticipated risks and the options available.
toxicology AND REGULATORY SUPPORT, CRO and study audits
I am a board-certified toxicologist (US and EU) and have more than 25 years of experience in toxicology, incl. designing, running, interpreting and reporting GLP toxicology studies (200+), and manage inspections by regulatory authorities. Regular interactions year with regulatory agencies (US FDA, China NMPA, Australia TGA) managing e.g. meetings (pre-IND etc.) and designations (Orphan Drug and Fast Track) etc. CRO selection, GLP/GMP vendor inspections / audits, GLP study monitoring.
APAC expertise
Being mostly based in Asia (Beijing, China), I have a unique access and familiarity with the CROs and CDMOs in China, and recently also India. Although these organizations are often US FDA-inspected and provide equal quality data compared to their Western counterparts, it is crucial - and these days also a regulatory expectation - to carefully oversee the conduct of your outsourced studies at all stages.
Contact
Use the form below to contact me. You can also email me: harri @ [this domain].